The death of a participant in a clinical trial by a Hyderabad-based contract research firm has refocused attention on the practices followed by an industry which is said to have great promise, because it can earn good dollars by leveraging cheap Indian skills.
The US Food and Drug Administration (USFDA) has asked Caraco Pharmaceutical Laboratories, the US subsidiary of Mumbai-based Sun Pharmaceuticals Industries, to withdraw many batches of its generic Metformin Hydrochloride tablets used for treating diabetes, citing efficacy and quality issues. According to a USFDA Class II withdrawal announced on March 19, Caraco will have to withdraw seven lots of Metformin Hydrochloride in bottles of 100, 500 and 1000 tablets each.
Three leading international pharma companies have started due diligence to acquire Wockhardt Ltd's wholly-owned Irish generic drug company, Pinewood.
Pharmaceutical majors like Ranbaxy, Dr Reddy's Lab, Wockhardt, Glenmark and Sun Pharma are now treading a careful patent litigation path in the US market to expand their generic business instead of the aggressive patent challenges they pursued until a few years ago.
Successive governments focused on altering the clearance processes but largely gave a pass to the second, and essential, element of environmental regulations for monitoring pollution levels and how industries followed conditions laid down for clearances.
The company has got the approval for the generic version of Roche's anti-viral 'Valcyte', which has a total annual market of around $239 million. Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby, providing a potential of 180-days of marketing exclusivity which offers a significant opportunity in the future, the company said.
While it's easy to look at Roadside Romeo as a harmless entertainer -- and there is a chance the film will indeed score very well with young audiences -- there is an inherent danger in the way it shoves even more Bollywood down the throats of its target audience.
The Saboteur is a game full of imperfections, but that's where its charm lies. If you're the kind to dissect and analyse a game's every facet, stay away. But if you're able to forgive its obvious flaws, it's a blast and well worth the time you will spend playing it.
India's largest drug maker Ranbaxy Laboratories, which is fighting a patent battle with the world's largest drug maker Pfizer on the cholesterol lowering drug Lipitor in about 18 countries, got a mixed verdict from the Full Court of Federal Court of Australia.
Sun generates 41 per cent of its annual revenues from the US market, a record of sorts among Indian drug firms. The company is bullish on its US prospects and expects 25 per cent growth in the country this year, higher than the 18-20 per cent growth projection it has given for other markets including India. The US is the world's largest market for medicines and accounts for nearly 50 per cent of the $780 billion global medicine sales.
Better-than-expected financial results in Q3 due to higher revenue growth and margins in key markets fuel the rally
Educational institutions in Canada offer courses ranging from eight months duration to two years, says Sushil Sukhwani
The joint entity will have a market share of nine per cent in India. Analysts tracking the company said one of the key outcomes of the merger would be to create a single brand entity of Sun and the Ranbaxy brand would eventually dissolve.
The Finland-based drug major Orion Corporation has filed a lawsuit in the United States against domestic drug major Wockhardt for challenging the patents on its brand Stalevo, used for the treatment of Parkinson's disease.
Mankind has presence in Sri Lanka, Myanmar, Cambodia, Kenya, Uganda, Zambia and Tanzania.
The Rs 3,290 crore (Rs 32.9 billion) Sun plans to sell Topamax in four strengths ranging from 25mg to 200mg, the combined market for which is estimated to be $2.5 billion. There is, of course, no litigation with the patent holder OrthoMcneill Janssen. The US market, which brings in about 40 per cent of Sun's consolidated sales and has driven revenues in the past few year could lose momentum.
The FDA Commissioner Margaret Hamburg is slated to travel to India soon.
A chilling ISIS manual has emerged online in which the dreaded outfit advised would-be jihadis from West to trim their beards and wear western-style clothes to avoid being identified.
Singh said they will focus on Fortis Healthcare and Religare Financial Services after the acquisition.
Indian coffee shops market over the next four-five years will grow between 6 and 18 per cent CAGR, all due to the growing coffee culture among the youth, increasing urbanisation, rising disposable income levels and changing eating and drinking preferences, says Atanu Biswas.
Initially, Toilet: Ek Prem Katha was about a newly married woman who fights for a toilet in her sasural. But then Akshay came into the picture....
Ranbaxy Laboratories, Dr Reddy's, Nicholas Piramal and three other Indian drug companies cut their research costs by separating the units involved in developing new drugs, thereby addressing investor concerns on low operating margins.
Ahmedabad-based Zydus Cadila, India's fourth largest pharma company with a turnover of Rs 2,300 crore, has acquired 100 per cent stake in Laboratorios Combix of Spain, marking its entry into Europe's fifth largest pharmaceutical market. The company bought the Spanish firm for an undisclosed amount.
Israel's pharma firm, Teva, is planning to invest Rs. 4000 crores in India.
The US drug regulator raised the issue of significant deviations from the current good manufacturing practice (cGMP) in three of DRRD's plants in a letter issued in November 2015
Drug major Ranbaxy Laboratories could suffer a potential revenue loss to the tune of Rs 300 crore (Rs 3 billion) due to delay in receiving approval from the US Food and Drug Administration (FDA) for generic version of GSK's anti-migraine medicine Imitrex, according to analysts.
Retail sales of Ranbaxy Laboratories, Cipla, Nicholas Piramal, Lupin and other drug makers have jumped by over 10 per cent in the domestic market despite the sales of generics or copycat versions of patented drugs falling in leading global markets such as the US and Europe.
I saw a fantastic Aamir Khan film the other night, one where his obsession with a pretty woman led to him being clubbed on the head with a generic looking rod.
In its ongoing patent litigation over cholesterol lowering drug atorvastatin (Lipitor) against India's Ranbaxy Laboratories, Pfizer said on Tuesday in a court in Ireland had ruled in its favour.
The drug regulatory agencies of India and Canada are planning to collaborate on improving the quality of drugs traded between the two countries, besides helping the industry in both the countries to tap the opportunities in the field of generic medicines and drug development.
Under fire from some United States senators for allegedly taking lenient positions in granting product approvals to generic companies from countries like India, the US FDA is planning to speed up its plans to set up offices in India by 2009. FDA, in its latest newsletter dated July 21, has said that the agency will set up offices in Mumbai and Delhi to intensify its monitoring efforts.
AvestaBiotherapeutic and Research (ABRPL) has signed a pact with Malaysian Biotechnology Corporation to develop biosimilar (similar biological products) products.
The pharmaceutical industry is expected to continue with its good performance in the first quarter of 2008-09 with over 25 per cent growth in revenues and about 45 per cent rise in net profit riding on better sales in the domestic and export markets. The industry will gain from the the depreciation of rupee as well.
Under fire in the United States for giving distorted information on the generic drugs it sold, Ranbaxy Laboratories on Tuesday said that it will file all relevant information within a month after which the legal case initiated against it by the US government will be withdrawn.
After making big-ticket acquisitions abroad, leading Indian pharmaceutical companies like Dr Reddy's Laboratories, Ranbaxy Laboratories, and Aurobindo Pharma are rapidly shifting production to their Indian facilities.
Of the top-10 global biotech companies, the biggest two -- Amgen and Biogen -- have already set up wholly owned subsidiaries in the country.
Sun Pharmaceutical Industries said on Monday it will acquire Israel-based Taro Pharmaceutical Industries Ltd, a multinational generic manufacturer, in an all cash deal for $454 million.
Sun Pharma has increased its stake in Israel's Taro by buying 9.5% more, raising its total holding to 34.4 per cent.
The Norwegian government has intervened in the high-profile case filed by Novartis against Indian patent laws by asking the drug company to withdraw the litigation.
Since Malvinder Mohan Singh announced last week that he would sell leading Indian generic drug maker Ranbaxy to Daiichi Sankyo of Japan, incredulous friends have deluged him with messages.
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